bismuth subcitrate potassium, metronidazole, and tetracycline

What is the most important information I should know about bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera)?

Do not use this medicine if you are pregnant or breast-feeding.

Tetracycline can make birth control pills less effective. Ask your doctor about using non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Pylera.

Do not give this medication to a child younger than 8 years old.

Do not drink alcohol while you are taking Pylera and for at least 1 day after you stop taking it.

Avoid taking Pylera with milk or other dairy products. Also avoid taking the medicine at the same time you take any multivitamins, mineral supplements, or antacids. These products can make it harder for your body to absorb Pylera.

What is bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera)?

Bismuth subcitrate potassium is a mineral.

Metronidazole and tetracycline are antibiotics that fight bacteria in the body.

Bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera) is a combination medicine used to treat peptic ulcer (duodenal ulcer) with H pylori infection. Pylera is usually given together with omeprazole (Prilosec).

This medication may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before taking Pylera?

You should not use this medication if:

you have kidney disease;

you are pregnant or breast-feeding;

you have taken disulfiram (Antabuse) in the past 14 days; or

you are allergic to bismuth subcitrate potassium, metronidazole, or tetracycline.

To make sure Pylera is safe for you, tell your doctor if you have:

liver disease;

a blood cell disorder; or

any type of infection.

Do not give this medication to a child younger than 8 years old. Tetracycline can cause permanent yellowing or graying of the teeth, and it can affect a child's growth.

FDA pregnancy category D. Do not use this medicine if you are pregnant. It could harm the unborn baby. Tetracycline can cause permanent tooth discoloration later in life and can also affect a child's growth.

Tetracycline can make birth control pills less effective. Ask your doctor about using non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Pylera.

Metronidazole and tetracycline can pass into breast milk and may harm a nursing baby. Do not breast-feed while you are using this medication or within 24 hours after your treatment ends. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

How should I take Pylera?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Pylera is usually given 4 times per day (after meals and at bedtime), while taking omeprazole 2 times per day (after breakfast and dinner). Follow your doctor's instructions.

Take your medicine with a full glass (8 ounces) of water. Swallow the capsule whole.

Pylera may cause your tongue to become darker in color. It may also cause your stools to appear black in color. These are harmless and temporary side effects.

Take this medicine for the full prescribed length of time, usually 10 days. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Pylera will not treat a viral infection such as the common cold or flu.

If you need surgery, tell the surgeon ahead of time that you are using Pylera. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss more than 4 doses, call your doctor for instructions.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Pylera?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Pylera and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Do not drink alcohol while you are taking Pylera and for at least 1 day after you stop taking it. Drinking alcohol while taking Pylera may cause nausea, vomiting, headache, or flushing (warmth, redness, tingly feeling).

Check the labels of any medicines or food products you use to make sure they do not contain alcohol.

Avoid taking Pylera with milk or other dairy products. Also avoid taking the medicine at the same time you take any multivitamins, mineral supplements, or antacids. These products can make it harder for your body to absorb the medicine.

Avoid exposure to sunlight or tanning beds. Pylera can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of Pylera?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Pylera?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Pylera, especially:

cimetidine;

lithium;

penicillin;

a blood thinner such as warfarin, Coumadin; or

seizure medication such as phenobarbital or phenytoin.

This list is not complete. Other drugs may interact with Pylera, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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